​​Trial Feasibility and Selection Under ICH E6(R3) Guidance​

​​Selecting the right clinical trials is one of the most important decisions a research site can make.

This course provides a practical framework for assessing trial feasibility and selecting trials that align with your site’s capabilities, patient population, and strategic goals. Applying ICH GCP E6(R3) principles to site-level feasibility decisions, you will learn how to use historical trial performance data, current patient population data, and the four key feasibility elements, interest, accruability, capacity, and trial portfolio alignment, to evaluate protocols, identify potential risks, support participant-focused trial conduct, and make informed, defensible trial selection decisions. You will also explore strategies for building a balanced trial portfolio that supports sustainable growth and successful trial execution. Included tools: Trial Selection/Protocol Review Worksheet, Best Practice Tip Sheet, Balanced Trial Portfolio Worksheet, and Self/Organizational Assessment.

At the end of this course, participants should be able to:

• ​​Explain how trial feasibility decisions may affect enrollment, retention, participant protection, data reliability, trial quality, and access to a clinical trial.
• ​Apply relevant ICH GCP E6(R3) principles to risk-informed, site-level trial selection decisions.  
• Use historical trial performance and current patient-population data to evaluate feasibility risk. 
• Assess proposed trials using the four feasibility elements: interest, accruability, capacity, and trial menu alignment.